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A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET) (REMINET)

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ClinicalTrials.gov Identifier: NCT02288377
Recruitment Status : Recruiting
First Posted : November 11, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE November 11, 2014
Last Update Posted Date June 13, 2018
Actual Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
Rate of patients alive and progression free at 6 months [ Time Frame: estimated 6 months after the last patient is randomized ]
To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria (version 1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02288377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2014)
  • Rate of patients alive and progression free at 12 months [ Time Frame: estimated 12 months after the last patient is randomized ]
    To evaluate the rate of patients alive and progression free at 12 months, assessed by the investigator according to RECIST criteria (version 1.1)
  • Safety [ Time Frame: estimated 6 months after the last patient is randomized ]
    Safety: the toxicities will be described using the NCI-CTC AE version 4.0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)
Official Title  ICMJE A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT
Brief Summary This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.
Detailed Description

This is a European, prospective, multicentre, double-blind randomised study evaluating lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

Depending on the phase II results, the study may be continued into phase III. The treatment and follow-up of patients will be the same in phase II and phase III.

After the first-line treatment, patients will be randomly assigned with a 1:1 ratio to receive either lanreotide or placebo. The study treatment should be initiated within 6 weeks following the confirmation date of stable disease or objective response.

Treatment period:

For each patient, the investigational products (lanreotide or placebo) will be provided according to a double-blind procedure until disease progression or toxicity, in accordance with the protocol.

The estimated average treatment duration for all patients is 12 months.

Follow-up period:

To evaluate overall survival, patients in phase II will have a minimum follow-up period of 12 months; if the study continues to phase III, these patients will have a maximum follow-up period of 10 years. Phase III patients will have a minimum follow-up period of 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours
Intervention  ICMJE
  • Drug: lanreotide
    Patients will receive lanreotide 120 mg every 28 days until disease progression
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: lanreotide
    In this arm, patients will receive lanreotide 120 mg every 28 days until disease progression
    Intervention: Drug: lanreotide
  • Placebo Comparator: placebo
    In this arm, patients will receive placebo every 28 days until disease progression
    Intervention: Drug: Placebo
Publications * Lepage C, Dahan L, Bouarioua N, Toumpanakis C, Legoux JL, Le Malicot K, Guimbaud R, Smith D, Tougeron D, Lievre A, Cadiot G, Di Fiore F, Bouhier-Leporrier K, Hentic O, Faroux R, Pavel M, Borbath I, Valle JW, Rinke A, Scoazec JY, Ducreux M, Walter T. Evaluating lanreotide as maintenance therapy after first-line treatment in patients with non-resectable duodeno-pancreatic neuroendocrine tumours. Dig Liver Dis. 2017 May;49(5):568-571. doi: 10.1016/j.dld.2017.02.004. Epub 2017 Mar 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
118
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2014)
222
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic (synchronous or metachronous) or locally advanced, non-resectable, well-differentiated duodeno-pancreatic neuroendocrine tumour, of grade 1 or 2 (WHO 2010 classification; Ki-67 ≤ 20%)
  • Progressive before first-line treatment
  • Histologically confirmed (either on primary tumour or metastases)
  • Pathological diagnosis validated by the NET consulting pathologist
  • Documented stable disease or objective response after first-line treatment, within 4 weeks (28 days) prior to randomisation
  • The first-line treatment will consist of either a chemotherapy or biotherapy (everolimus or sunitinib) as referred to TNCD or ENETS guidelines. Treatment must have been administered for 3 to 6 months for chemotherapy and for 6 months for biotherapy
  • Non-functional tumour or gastrinoma controlled by PPIs
  • Age > or = 18 years
  • WHO 0, 1 or 2
  • Effective contraception for male or female patients of childbearing age, defined as: oral contraceptives, intra-uterine devices, barrier contraceptive methods along with a spermicide gel, or surgical sterilisation. Female patients should use this contraception throughout the treatment period and for 6 months after the last treatment administration. Male patients should use contraception throughout the treatment period and for 3 months after the last treatment administration.
  • Signed informed consent prior to initiation of any study-specific procedures or treatment.

Exclusion Criteria:

  • History of haematological malignancy or other cancer, except those treated for more than 5 years and considered as cured, carcinoma in situ of the cervix and treated skin cancer (excluding melanoma)
  • Poorly differentiated neuroendocrine carcinoma or NET grade 3 ENETS (Ki-67 > 20%)
  • If primary resected, bone metastasis exclusively
  • Pre-treatment by somatostatin long-acting analogue
  • Total bilirubin ≥ 60 µmol/L
  • Uncontrolled diabetes
  • Contraindication to product used in the study or its components
  • Tumour arising in the context of a genetic disease
  • Pregnancy or lactation
  • Patients unable to undergo medical follow-up due to geographical, social, psychological or legal reasons
  • Concomitant participation in another clinical trial investigating a treatment during the treatment phase and within 30 days prior to the start of the study treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lila GABA +33 3 80 39 34 83 lila.gaba@u-bourgogne.fr
Listed Location Countries  ICMJE Belgium,   France,   Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02288377
Other Study ID Numbers  ICMJE PRODIGE31
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Federation Francophone de Cancerologie Digestive
Study Sponsor  ICMJE Federation Francophone de Cancerologie Digestive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Come Lepage, Pr Federation Francophone de Cancerologie Digestive
PRS Account Federation Francophone de Cancerologie Digestive
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP